This invention relates to irrigation systems for surgical procedures and, more particularly, to a lightweight, portable, disposable surgical irrigation system.
Nondisposable surgical irrigation systems that supply sterile fluid for flushing and cooling a surgical cutting site are well known. Such systems generally cool a particular region of a cutting tool or cutting site and flush the cut debris from the cutting site.
As used herein, the term "cutting" is also intended to include drilling.
Cooling the cutting tool and/or the cutting site helps keep the cut surface of bone and/or tissue at a low enough temperature to prevent thermal necrosis. A continuous removal of cut debris during the surgical cutting process usually facilitates the surgical operation and permits greater accuracy in the surgery than systems without irrigation. Surgical accuracy is particularly important in microsurgery procedures, where visual access is vital and the margin for error is extremely small.
Examples of procedures that either use or would benefit from surgical irrigation systems include oral endosseous implants, removal of third molars (wisdom teeth) when high speed drilling is required to split the tooth, otology (ear surgery) where irrigation is presently used to remove blood and debris while cutting an access hole through the temporal bone in preparation for a cochlear implant, oral maxillofacial surgery, spinal surgery, revision surgery of the femoral canal, arthroscopic surgery, orthopedic surgery, particularly total knee replacement, and other procedures.
Conventional surgical irrigation systems often employ a relatively heavy immobile reusable systolic pump with an attachable pre-sterilized tubing set. The tubing, which is disposable, is removed and discarded after a surgical procedure is completed. A typical method of attaching new tubing to the pump prior to surgery is to disassemble the pump head, insert the new tubing over the pump rollers, and reassemble the pump.
The systolic pump system evolved in response to a need for sterile irrigants. The power systems and pumps used prior to the development of the systolic system could not be effectively sterilized and therefore required an interacting sterile system. However, the systolic pump system is cumbersome to disassemble and reassemble for the purpose of replacing used tubing with sterile tubing. Furthermore, the tubing used in a systolic pump must be of a certain hardness or Durometer in order to effectively deliver a required flow of irrigant to a cutting site. Also, some training and dexterity is required to disassemble and assemble the systolic pump system.
Although the systolic system can deliver different flow rates by changing pump speed, the type of flow produced is of a pulsing nature as the systolic rollers alternately compress and release the tubing. Moreover, some low power systolic pumps require a relatively soft section of tubing, such as natural rubber, at the portion of the system that contacts the pump rollers. This need for relatively soft tubing increases the complexity of the systolic pump system and can lead to a problem of improper functioning of the pump if the tube is not correctly installed.
Another known system for delivering sterile irrigant includes a pressure vessel surrounding a flexible bag of irrigant. The bag is attached through a pressurizing device to pre-sterilized tubing. Flow of liquid through the tubing is achieved by pressurizing the container to compress the flexible bag. The tubing is removed and discarded after each surgical procedure is completed.
The pressure vessel system also has inherent problems in that a sterile interface is required between the irrigant reservoir (the flexible bag of irrigant) and the exterior tubing. A sterile interface can be accomplished with sterile fittings but is cumbersome to set up. Moreover, the pressure vessel is relatively large compared to the flexible bag of irrigant and requires a source of pressurized gas, which can explode if overpressurized or incorrectly assembled. In addition, irrigant flow must be controlled by the use of a tubing pinch roller, which is generally imprecise.
It is thus desirable to provide a completely disposable portable irrigation system that can be precisely controlled, is nonhazardous, simple to set up and use, highly mobile, and does not require any assembly or disassembly of the pumping apparatus.